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QuickOpt Chronic Study

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cardiac Resynchronization Therapy
Optimization using echocardiography
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring CRT, heart failure, optimization, Timing cycle optimization methods

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Patient meets current CRT-P indications and be implanted with an SJM CRT-P device with V-V timing and a compatible lead system

    • Patient is able to provide written informed consent for study participation

Exclusion Criteria:

  • • Patient has limited intrinsic atrial activity (≤ 40 bpm)

    • Patient has persistent or permanent AF
    • Patient has a 2o or 3o heart block
    • Patient's life expectancy is <12 months
    • Patient is <18 years old
    • Patient is pregnant
    • Patient is on IV inotropic agents
    • Patients who are ongoing other devices or agents study
    • Patients with heart transplanted or waiting for heart transplant
    • Patients with Hypertrophic and obstructive cardiomyopathy
    • Patients with severe aortic valve and mitral valve stenosis or regurgitation without replacement

Sites / Locations

  • Fuwai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Quickopt Group

Echocardiography group

Arm Description

the QuickOpt Group patients will be optimized by QuickOpt(IEGM);

the Echo Group patients will be optimized by Echo.

Outcomes

Primary Outcome Measures

Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline
The primary outcome is the percent change in LVESV at 12 months compared to baseline. This outcome measure is assessed through evaluation of echocardiograms at both baseline and 12 months, with a decrease in the percent change in LVESV at 12 months indicating clinical improvement. The percent change in patients with devices optimized with QuickOpt is compared with that of patients with devices optimized using standard echocardiography techniques to determine if one method of optimization results in a greater change in LVESV.

Secondary Outcome Measures

Full Information

First Posted
July 28, 2010
Last Updated
September 27, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01172067
Brief Title
QuickOpt Chronic Study
Official Title
Clinical Impact of Cardiac Resynchronization Therapy on Heart Failure Patients With QuickOpt and Echo Optimization
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to demonstrate that QuickOpt optimization can be as an alternative method for CRTP/D patients' optimization in clinical practice through the comparison of the improvement differences between the CRTP/D patients with different optimization at 12 months after implantation.The hypothesis is that the Heart Remolding parameter (LVESV) improvement of patients using QuickOpt parameters at 12 months after implant is not inferior (10%) to the patients by Echo optimization。
Detailed Description
Clinical studies have demonstrated that the AVTI from QuickOptTM related significantly to the max aorta VTI (AVTI) by Echo, the concordance correlation coefficient (CCC) was so high from 0.96 to 0.99. But up to now, there are no clinical trials to evaluate mid-long term clinical outcome for CRTP/D patients by QuickOptTM and Echo optimization, this is indeed the main purpose of the study; in addition, the clinical impact, the status of arrhythmia and agents of all the enrolled patients, will be evaluated at 1 year after implant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
CRT, heart failure, optimization, Timing cycle optimization methods

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quickopt Group
Arm Type
Experimental
Arm Description
the QuickOpt Group patients will be optimized by QuickOpt(IEGM);
Arm Title
Echocardiography group
Arm Type
Active Comparator
Arm Description
the Echo Group patients will be optimized by Echo.
Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronization Therapy
Intervention Description
Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.
Intervention Type
Device
Intervention Name(s)
Optimization using echocardiography
Intervention Description
Optimization of the AV/PV and VV delays using echocardiography
Primary Outcome Measure Information:
Title
Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline
Description
The primary outcome is the percent change in LVESV at 12 months compared to baseline. This outcome measure is assessed through evaluation of echocardiograms at both baseline and 12 months, with a decrease in the percent change in LVESV at 12 months indicating clinical improvement. The percent change in patients with devices optimized with QuickOpt is compared with that of patients with devices optimized using standard echocardiography techniques to determine if one method of optimization results in a greater change in LVESV.
Time Frame
Baseline and12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Patient meets current CRT-P indications and be implanted with an SJM CRT-P device with V-V timing and a compatible lead system Patient is able to provide written informed consent for study participation Exclusion Criteria: • Patient has limited intrinsic atrial activity (≤ 40 bpm) Patient has persistent or permanent AF Patient has a 2o or 3o heart block Patient's life expectancy is <12 months Patient is <18 years old Patient is pregnant Patient is on IV inotropic agents Patients who are ongoing other devices or agents study Patients with heart transplanted or waiting for heart transplant Patients with Hypertrophic and obstructive cardiomyopathy Patients with severe aortic valve and mitral valve stenosis or regurgitation without replacement
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China

12. IPD Sharing Statement

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QuickOpt Chronic Study

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